Beverages for Thought: Exploring the Relationship Between Blood Glucose and Cognition

January 9, 2024 updated by: Julie Hess, USDA Grand Forks Human Nutrition Research Center
The objective of this study is to conduct novel research on the relationship between blood sugar and cognition.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is an acute parallel study design with one intervention visit needed per participant. There are 2 groups and 80 participants will be randomized into each group. Following the consent process, participants in each group will be seated individually in quiet rooms, with written instructions, several magazines, and a mini-fridge with beverages containing 110-120 kcals/8 fl oz. Participants will be provided instructions for the study, stating, "The study we are conducting explores the relationship between blood glucose and cognitive abilities. After consuming food or drink, your body regulates your blood glucose. Physical exertion can also affect blood glucose. Therefore, we ask that you relax in this space for 10-15 minutes. You can read the provided magazines during this time. Drinking a beverage will bring your body's blood glucose into the right phase for our questionnaires. In the fridge are some beverages, and we ask that you drink something."

After 10-15 minutes, participants will be given a cognitive test (a questionnaire on paper) and asked to complete as much of it as they can within 5 minutes. Then, moving to a separate area, weight and height measurements will be taken.

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • North Dakota
      • Grand Forks, North Dakota, United States, 58203
        • Recruiting
        • USDA Grand Forks Human Nutrition Research Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy weight to overweight (BMI 18.5-29.9 kg/m2)
  • No food allergies or food intolerances
  • Healthy (no chronic disease) as determined by online questionnaire
  • Non-pregnant and non-lactating
  • Not currently dieting or planning to follow a special diet
  • Minimal restricted eating practices

Exclusion Criteria:

  • Obesity (BMI ≥ 30 kg/m2)
  • Pregnant or lactating
  • Currently dieting or planning to follow a special diet

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Beverage One (Milk)
Participants will consume milk prior to completing a novel cognitive assessment on paper.
Other: Beverage One (Milk)
Participant will consume beverage one (milk) and complete novel cognitive assessment questionnaire on paper.
Experimental: Beverage Two (Juice)
Participants will consume a fruit drink prior to completing a novel cognitive assessment on paper.
Other: Beverage Two (Juice)
Participant will consume beverage two (fruit drink) and complete novel cognitive assessment questionnaire on paper.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Written cognitive task results from novel cognitive assessment questionnaire.
Time Frame: 10 minutes post beverage ingestion
Results of cognitive task after consuming a study beverage (milk or fruit-flavored drink). More questions answered correctly results in a higher score. The assessment has a total of 10 questions, and participants will be asked to complete as much of this assessment as they can within a 5 minute timeframe.
10 minutes post beverage ingestion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

USDA Grand Forks Human Nutrition Research Center

Investigators

  • Principal Investigator: Julie Hess, PhD, USDA Grand Forks Human Nutrition Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 23, 2023

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

May 4, 2023

First Submitted That Met QC Criteria

May 24, 2023

First Posted (Actual)

June 5, 2023

Study Record Updates

Last Update Posted (Estimated)

January 11, 2024

Last Update Submitted That Met QC Criteria

January 9, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GFHNRC156

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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